At his clinic and research group in Bothell, John Catanzaro, a naturopathic physician, told cancer patients he was on the cutting edge of research, developing treatments to improve their immune systems and cancer-fighting capabilities.

To do that, he said, he was creating individualized “autologous peptide and cytokine-based vaccines” from patients’ own blood, body tissues and fluids — experimental injections not covered by insurance that can cost families tens of thousands of dollars a year.

Although Catanzaro characterized his work as research, and told investigators he informed patients the vaccines were experimental, the state says he lacked proper documentation. Further, the state alleges, although Catanzaro originally told investigators he had the oversight and the Food and Drug Administration permit required for research, he could not produce evidence of that, and he told investigators he had not collected research data on the vaccine’s effectiveness or adverse effects.

“These vulnerable cancer patients are led to believe that the vaccine is effective based on patient testimonials but (Catanzaro) has not compiled actual research to demonstrate efficacy,” the state’s charging document said.

Such allegations of improperly conducted research against a naturopathic physician are unusual, according to Janelle Cognasso, disciplinary case manager for the Board of Naturopathy. “It’s the first case I’m aware of this type.” State records show the emergency suspension of Catanzaro’s license is the first such action against a naturopathic physician since 1987.

Catanzaro has until March 14 to respond to the state administrative charges. The board could dismiss the charges, negotiate a settlement or impose sanctions up to the loss of his license.

In an email to The Seattle Times, Catanzaro said his legal team advised him to refrain from comment. A statement by Catanzaro on the clinic’s website says: “We disagree with the (Department of Health) and are appealing.”

He added that patient care at his clinic, which includes three other naturopathic physicians, would not be interrupted. If the vaccines are continuing without research permits the state says are needed, that could prompt further investigation.

Questions surrounding the naturopath’s practice have also drawn in the popular Mars Hill Church, where Catanzaro became known as Pastor Mark Driscoll’s friend and doctor and gained exposure as a frequent contributor to the church’s Resurgence blog.

Whether Catanzaro’s vaccines helped, hurt or had no effect on his cancer patients is not clear from interviews or from documents the state has made available.

As the case moves forward, two views of Catanzaro have emerged.

One is that he is a sincere and dedicated healer so intent on helping and bringing hope to cancer patients through what he described as “cutting-edge” treatments that he didn’t attend to paperwork. In blogs and testimonials, patients have praised him for taking bold steps beyond conventional care, and seeing terminal patients who otherwise have no hope.

The other view is that he is a reckless scientist-wannabe who ignored state and federal regulations aimed at protecting patients who become research subjects, and that he peddled false hope and costly treatments to vulnerable cancer patients.

“Catanzaro is either a boldfaced liar and whatever he was doing was a lie, or he’s just terribly negligent,” said a family member of a former patient who believed the treatments were beneficial, but is now confused. “For all we know, he’s got the cure for cancer, but no one is ever going to know, because he could lose his license.”

Practitioner since ’90s

Catanzaro, 54, earned a doctor of naturopathic medicine degree from Bastyr University in Kenmore in 1995 and was licensed by the state in 1996.

Soon afterward, he began the Health & Wellness Institute;

in early 2007, he founded nonprofit HWIFC Cancer Research Group “at the recommendations and donations of patients that were helped by integrative immune therapy,” according to the clinic’s website.

That year, the state said he had prescribed medications, such as antibiotics, to 18 patients over a three-year period that naturopaths weren’t allowed to prescribe. The case was settled after he paid a fine and completed further education in professional ethics and legal requirements for his profession.

In a blog post a few years ago, Catanzaro said he had treated more than 50,000 patients, including more than 2,000 with cancer.

Like other naturopathic practitioners, Catanzaro has said his aim is to stimulate a patient’s immune system to recognize cancer and fight it — an intuitively persuasive idea that has in the past few years received much attention from the scientific community, the pharmaceutical industry and private funders.

Over the past decade, naturopathy and conventional treatment have increasingly integrated. Some cancer-treatment centers, such as Cancer Treatment Centers of America (CTCA), also offer natural, nontoxic therapies to “treat the whole person and encourage the self-healing process.”

The goal, CTCA says, is to reduce harmful effects of cancer treatments, through such avenues as boosting immune function with homeopathic remedies.

Despite such cooperation between the two approaches,
tension — and suspicion — remain.

Naturopathic physicians who obtain specialty board certification in oncology can help patients in a “collaborative model of cancer co-treatment” and guide them through “the multitude of ‘alternative therapies’ promoted to cure cancer,” according to the Oncology Association of Naturopathic Physicians. Catanzaro is not board certified in the field, according to its executive director, Corey Murphy, of Portland.

Patient blogs and interviews suggest that Catanzaro, the author of a book on integrating conventional and alternative approaches, did not push his patients to abandon conventional treatment: Naturopathic physicians in this state are prohibited from treating cancer except in collaboration with a licensed medical or osteopathic physician.

On his LinkedIn profile, Catanzaro says he is working on “cancer proteomics and molecular genetics” with scientists at Dana-Farber Cancer Institute, a respected Boston research institution linked with Harvard University.

A spokeswoman at Dana-Farber said Catanzaro had no connection there, beyond one or two phone conversations with one of its leading cancer researchers.

“We have investigated the matter and requested that Dr. Catanzaro cease all unauthorized use of our name,” spokeswoman Teresa Herbert said in an email.

Soon after his license was suspended, Catanzaro mused in a blog post about why he began treating cancer. He quoted iconoclastic musician Frank Zappa (“Without deviation from the norm, progress is not possible”), criticized researchers who “waste time on animal studies for decades,” and called for a shift toward alternative treatments to give patients “personalized options.”

He recalled that when he had just graduated from Bastyr’s naturopathic medical program “with a plethora of knowledge,” he was called upon to help a young cancer patient with late-stage breast cancer.

He said he “extracted proteins from her urine and serum and injected her with her own proteins,” along with “immune-boosting bio-nutrients,” which he claimed helped her live more good years.

“This is why I began treating cancer. I have not become case hardened and hopeless, but inspired to do better and not withhold promising therapy that is safe,” he wrote.

Religion in the mix

Until recently, Catanzaro’s posts, which often urged people to come to “know Jesus Christ as personal Savior, Guide and Friend,” enjoyed prime real estate on Mars Hill’s Resurgence blog.

Within days of the state suspending Catanzaro’s license, any reference to him was removed from the Mars Hill websites, and some blogs by church-member patients that earlier had been accessible to the public were closed.

Driscoll, Mars Hill’s evangelical Christian founder, in his forward to a book by Catanzaro on the medical aspects of marijuana, referred to Catanzaro as “my doctor and friend.”

Driscoll did not respond to requests seeking comment.

Current and former members of Mars Hill said Driscoll often spoke from the pulpit about the doctor who helped him turn his general health around.

Though none remembers him mentioning Catanzaro by name, it was clear whom he meant. They saw the praise as a tacit endorsement by an influential pastor they trusted and respected. And some said they appreciated a doctor who would pray with them and respect their faith-based approach to all forms of health care.

“It’s no surprise (Catanzaro’s) practice has done well, being connected to such a huge organization as Mars Hill,” said one former member, who like many did not want to be named because both the church and alternative treatments prompt such strong feelings.

Driscoll talked about how Catanzaro’s treatments for low energy “were setting him on a true and right course and he was sleeping better and on and on,” said Rob Smith, a former deacon who said he was forced out of the church during an upheaval in 2007. “He extended credibility by just talking about it from the pulpit.”

For about two years beginning around 2006, Smith’s wife, Merle, received regular vitamin B injections for chronic fatigue at Catanzaro’s clinic.

Driscoll’s connection with the clinic “made us feel more comfortable with him, no question about that,” Rob Smith said.

Patient safety at issue

Faith issues aside, the state’s case against Catanzaro lands squarely on his experimental treatments and patient safety. What he has been doing, the state contends, amounts to research on human beings, something that requires obtaining certain federal and state permits, securing oversight for the “human subjects” involved, and record keeping to document the effects.

Catanzaro’s apparent failure to collect research data, the Board of Naturopathy said, “is unethical and lowers the standing of the profession.”

Susan Gragg, program manager for the board, said she was not aware of any statute or rule specifically prohibiting a naturopathic physician from injecting patients with their own bodily substances.

State regulations note that “the use of a nontraditional treatment by itself shall not constitute unprofessional conduct, provided that it does not result in injury to a patient or create an unreasonable risk that a patient may be harmed.”

Because Catanzaro’s charting lacks specific test results that could document “adverse impacts” and effectiveness, the state said, “there is no way to demonstrate any level of safety. Because this data does not exist, (Catanzaro’s) research protocol is unsafe for patients.”

In addition, the vaccine he was using qualifies as a drug under federal regulations, Gragg added, and must be made in a lab complying with specified rules.

Asked whether a doctor actually needs a federal permit to inject a single patient with an experimental “vaccine” derived from his or her own body, FDA spokeswoman Jennifer Rodriguez said: “As general background on INDs (investigational new drug research permits), the fact that a product is only intended for use on a single patient would not eliminate the need for an IND. The regulations provide for single patient INDs.”

Although the state doesn’t address the issue in its action against Catanzaro, patients have blogged about having to fundraise to pay for the experimental vaccines. Some families said they were paying about $15,000 per treatment for the cancer vaccine, which was not covered by insurance and ideally would be given up to three times a year, along with other injections and supplements.

Patients enrolled in research studies typically are not charged for the treatment being researched, according to the National Cancer Institute and Seattle Cancer Care Alliance.

The family of one patient said they paid more than $100,000 for cancer vaccines and additional supplements from Catanzaro during a roughly two-year period. Catanzaro assured them that he was working with well-known institutions and had data on the treatment’s effectiveness, the family said.

Dr. Nora Disis, a professor of medicine at the University of Washington specializing in oncology and tumor vaccines, said if she were doing what the state says Catanzaro was, she would need a scientific review, human subjects oversight, an investigational drug permit and a certified lab, be required to report to outside boards monitoring safety and effectiveness and get outside audits.

Based on the information available on the clinic’s website, Disis said it appeared the vaccines, if produced correctly in a safe laboratory, probably would pose little risk to patients.

But, she added, they also would be unlikely to provide benefit. The approach to cancer vaccines that Catanzaro has described, she said, appeared to be “quite old technology.”